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Safety Information

Revised: 30 May 2017

Overview of how Medsafe manages medical device adverse event reports and reports of medical device quality issues

Medsafe receives reports of issues associated with the use of medical devices from users, healthcare professionals and the medical device industry. The reports can be received via faxes, letters and e-mails. These reports are entered into Medsafe's regulatory database by Medsafe staff. All reports are checked by us for correctness and completeness. 

How to report a problem

Risk Assessment

All reports are entered into a database, assessed for risk and further investigated as appropriate.

Investigation

The investigator will:

Final outcomes may include:

Medsafe also exchanges information on significant incident investigations with overseas regulatory authorities.

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